Device recall
Z-0019-2025: Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis…
FDA device recall · Class II · Outset Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0019-2025 |
|---|---|
| Recall event | 95294 |
| Product | Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. |
| Product code | KDI |
| Recalling firm | Outset Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K233335 |
| FEI number | 3010355846 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database